Dental CrownsNCT07797972
Prospective Clinical Evaluation of Posterior Single-tooth Zirconia Ceramic Restorations
An observational study of Dental Crowns, run by University of Pennsylvania at 1 site in United States.
Trial summary
This prospective, controlled, open clinical product surveillance trial will evaluate the performance of posterior zirconia ceramic crowns over 24 months Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Crowns
- What is being tested?
- IPS e.max® ZirCAD Prime Esthetic
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Recruitment will be conducted by advertisements in local newspapers and at academic institutions. Patients will also be recruited from within Penn Dental Medicine's undergraduate and postgraduate student clinics.
Who may be able to join
- At least 18 years of age (selected regardless of sex, race or other ethnic characterization)
- Vital or endodontically treated tooth
- Antagonist present
- Classify as ASA I or ASA II according to the American Society of Anesthesiologists (ASA)
- In need of an indirect full-coverage restoration (crown) on at least one posterior tooth (premolar or molar)
- Fulfilling all medical and dental requirements for preparation of a full-coverage crown
Show all 13Show fewer
- Angle Class I occlusal relationship with a minimum of 20 remaining teeth
- Adequate intra-arch space allowing for satisfactory restoration of the abutment teeth. If opposing teeth have supra-erupted, an ideal occlusal plane will be restored by enameloplasty. In cases of severe supra-eruption, patients will need to consent to alternative means of restoring an ideal plane of occlusion. This may involve surgical crown lengthening and/or restoration of the tooth. Otherwise, they will be excluded from the study.
- Dentition free of active periodontal disease (probing depth and attachment levels at within normal limits, no furcation involvement, no mobility). Individuals meeting other criteria but presenting with active periodontal disease will be referred to the Post-Graduate Periodontal Clinic for treatment and subsequently re-screened.
- Willingness and ability to comply with the pre- and post-operative diagnostic and clinical evaluations required for the study.
- Willingness and ability (including financial) to comply with the final restorative treatment plan that will be accomplished upon completion of participation in the study.
- Willingness and ability to understand and comply with Institutional Review Board (IRB)/Ethics Committee requirements as outlined in consent forms, which have to be signed by the patients.
- Subjects are responsible for payment of regular dental procedures.
Who cannot join
- Severe wear facets and/or parafunctional activities such as clenching or nocturnal bruxism
- Pulpitis, no hypersensitivity on biting and temperature (visual analog scale <3)
- Insufficient endodontic treatment
- Periapical pathology
- Pregnancy during the treatment phase
- Significant medical conditions or drug use that could interfere with evaluation (i.e., narcotics, NSAIDs)
- Medical conditions that preclude the subject from carrying out oral hygiene regimens (i.e., severe arthritis affecting the hands)
- Social history that indicates a risk of poor compliance (i.e., history of alcohol or drug abuse) with proper maintenance of restoration
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Dental Medicine
Philadelphia, Pennsylvania, 19104
About this study
This prospective, controlled, open clinical product surveillance trial will evaluate the performance of posterior zirconia ceramic crowns over 24 months
Read the detailed description
This prospective, controlled, open clinical product surveillance trial will evaluate the performance of posterior zirconia ceramic crowns over 24 months. A total of 40 indirect full-coverage crowns will be fabricated from zirconia ceramic (IPS e.max® ZirCAD Prime Esthetic, Ivoclar Vivadent, Schaan, Liechtenstein) and cemented with ZirCAD Cement (Ivoclar Vivadent), a resin modified glass ionomer luting cement. Clinical evaluation parameters restorations in terms of fracture resistance, marginal adaptation, shade/color match, and other complications will be assessed at baseline and then 6 months, 1 year, and 2 years postoperatively. Descriptive statistics will be used and survival analysis will be estimated with Kaplan-Meier survival analysis.
- Conditions
- Dental Crowns
- Being tested
- IPS e.max® ZirCAD Prime Esthetic
- Keywords
- dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPS e.max® ZirCAD Prime EstheticCombination product
Full-coverage crowns will be fabricated from zirconia ceramic discs (IPS e.max® ZirCAD Prime Esthetic, Ivoclar Vivadent, Schaan, Liechtenstein) and cemented with ZirCAD Cement (Ivoclar Vivadent) a resin modified glass ionomer luting cement.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving receiving zirconia ceramic restorations | Not described Receives: Combination Product: IPS e.max® ZirCAD Prime Esthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival analysis
Survival analysis will be estimated using Kaplan-Meier survival analysis. Based on the following variables; restoration loss and FDI criteria (Marginal fit, Shade/Color Match, and Incidence of complications)
Measured: From day 1 of crown placement to follow-up visits at 6, 12, and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start9 May 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CrownsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797972
- Sponsor's protocol ID
- 20-0251(842650)
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of Posterior Single-tooth Zirconia Ceramic Restorations
- ClinicalTrials.gov ID
- NCT07797972
- Acronym / sponsor ID
- 20-0251(842650)
- Conditions
- Dental Crowns
- Keywords
- dental
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Study start
- 9 May 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, controlled, open clinical product surveillance trial will evaluate the performance of posterior zirconia ceramic crowns over 24 months
Detailed description
This prospective, controlled, open clinical product surveillance trial will evaluate the performance of posterior zirconia ceramic crowns over 24 months. A total of 40 indirect full-coverage crowns will be fabricated from zirconia ceramic (IPS e.max® ZirCAD Prime Esthetic, Ivoclar Vivadent, Schaan, Liechtenstein) and cemented with ZirCAD Cement (Ivoclar Vivadent), a resin modified glass ionomer luting cement. Clinical evaluation parameters restorations in terms of fracture resistance, marginal adaptation, shade/color match, and other complications will be assessed at baseline and then 6 months, 1 year, and 2 years postoperatively. Descriptive statistics will be used and survival analysis will be estimated with Kaplan-Meier survival analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving receiving zirconia ceramic restorations | – | Combination Product: IPS e.max® ZirCAD Prime Esthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Recruitment will be conducted by advertisements in local newspapers and at academic institutions. Patients will also be recruited from within Penn Dental Medicine's undergraduate and postgraduate student clinics.
Key inclusion criteria (13 listed)
- At least 18 years of age (selected regardless of sex, race or other ethnic characterization)
- Vital or endodontically treated tooth
- Antagonist present
- Classify as ASA I or ASA II according to the American Society of Anesthesiologists (ASA)
- In need of an indirect full-coverage restoration (crown) on at least one posterior tooth (premolar or molar)
Key exclusion criteria (8 listed)
- Severe wear facets and/or parafunctional activities such as clenching or nocturnal bruxism
- Pulpitis, no hypersensitivity on biting and temperature (visual analog scale <3)
- Insufficient endodontic treatment
- Periapical pathology
- Pregnancy during the treatment phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPS e.max® ZirCAD Prime EstheticFull-coverage crowns will be fabricated from zirconia ceramic discs (IPS e.max® ZirCAD Prime Esthetic, Ivoclar Vivadent, Schaan, Liechtenstein) and cemented with ZirCAD Cement (Ivoclar Vivadent) a resin modified glass ionomer luting cement. | Combination product | Patients receiving receiving zirconia ceramic restorations |
Primary outcome
Survival analysis
Time frame: From day 1 of crown placement to follow-up visits at 6, 12, and 24 months.
Survival analysis will be estimated using Kaplan-Meier survival analysis. Based on the following variables; restoration loss and FDI criteria (Marginal fit, Shade/Color Match, and Incidence of complications)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Crowns
Not yet recruitingObservational study
Association Between Peri-implant Tissue Health and Crown Shape: a Prospective Study
Dental Implants
Active, not recruitingObservational study
Influence of Prosthetic Characteristics of Implant-Supported Crowns on Peri-implant Health and Osseointegration: A Comparison Between Digital and Conventional Workflows
Implant-supported Single Crowns, Osseointegration
Not yet recruiting
3D-Printed Resin Crowns Versus Bioflx Crowns in Primary Molars
Dental Restorations in Children, Pediatric Dentistry
Active, not recruiting
Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.
Dental Prosthesis Failure
Recruiting
Clinical Evaluation of Bioflx Crowns in Restoring Primary Anterior Teeth
Clinical, Primary Teeth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Crowns, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival analysis (time frame: From day 1 of crown placement to follow-up visits at 6, 12, and 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.